UNITED STATES
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CURRENT REPORT
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Item 8.01 | Other Events |
On May 30, 2023, Galera Therapeutics, Inc. (the “Company”) filed a lawsuit in the Court of Common Pleas in Chester County, Pennsylvania against Alira Health Clinical, LLC and IQVIA Biotech, LLC (the “CROs”) alleging breach of contract and negligence specifically related to an error by the CROs in 2021 in the statistical program for the Phase 3 ROMAN trial of avasopasem for the reduction of severe oral mucositis (“SOM”) induced by radiotherapy in patients with locally advanced head and neck cancer (the “Phase 3 ROMAN trial”) and seeking damages. In December 2021, the Company announced that the error in the statistical program for the Phase 3 ROMAN trial had been detected and that correction of this error yielded the correct, statistically significant p-values for the primary endpoint and a key secondary endpoint of the Phase 3 ROMAN trial.
This litigation is in its early stages, and the Company is unable to predict the outcome at this time.
As previously disclosed by the Company, in February 2023, the U.S. Food and Drug Administration accepted and granted Priority Review designation to the Company’s New Drug Application (“NDA”) for avasopasem for the reduction of SOM induced by radiotherapy. The Prescription Drug User Fee Act (PDUFA) target date for the NDA is August 9, 2023.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
GALERA THERAPEUTICS, INC. | ||||||
Date: May 30, 2023 | By: | /s/ J. Mel Sorensen, M.D. | ||||
J. Mel Sorensen, M.D. | ||||||
President and Chief Executive Officer |